Medicinal container



Apg-il 11, 1939.

P. e. HEINEMAN I MEDICINAL CONTAINER Filed April 3, 1936 INVENTORI I? G.Hezneman BY 4 irron EYs Patented Apr. 11, 1939 I I I UNITED STATESPATENT OFFICE MEDICINAL CONTAINER Paul G Heineman, Albany, N. Y.,assignor to Winthrop Chemical Company, Inc., New York, N. Y., acorporation oi. New York Application April 3, 1936, Serial No. 72,522

1 Claim. (01. 215-47) The object of this invention is a novel type ofThe elements of this combination which imclosed medicinal containerwhich will enable the part to it the aforementioned functions areillusphysician, or dentist, or veterinarian, to withdraw trated in theaccompanying sheet of drawings in from it into a hypodermic syringe, anaccurate which amount of its liquid contents, without difficulty Fig. 1is a view, partly in section, of an air 5 and without risk of microbialcontamination of filter;

the liquid from theair. Fig. 2 is a cross-sectional view of a stopper inMedicinal containers are usually made of glass accordance with myinvention; and they are commonly closed with rubber stop- Figs. 3 and 3aare the same, but illustrating pers or rubber caps. When filling thesyringe, the working of the air filter in cooperation with 10 theoperator must either remove the stopper or the stopper 6 (Fig. 3); andwith a container in cap, or he must puncture it with the hypodermicaspirating the solution into the syringe (Fig. 3a)

needle attached to the syringe. If the closure is Fig. 4 illustrates acombination of the stopper removed, communication with the air cannot bein Fig. 3 with a screw cap container. avoided. If it is not removed,difilculty arises in Figs. 5 and 6 demonstrate two modifications of 15aspirating the solution into the syringe through a cap as a closure inaccordance with my inventhe needle, because during removal of the liquidtion.

a partial vacuum is created in the closed contain- In Fig. 1, the airfilter I consists of a tube 2 er. The larger the amount to be withdrawn,the made of a suitable material, such as chromium greater is the suctioncaused by partial vacuum. plated steel, stainless steel, brass ornickel; also 20 Accuracy of dosage, therefore, is impaired. Bakelite,hard rubber or any similar substance The above disadvantages areparticularly nomay be used. The tube 2 is equipped with a ticeable with"multiple dose containers. which in thumb-rest 3 and a beveled aperture4; in its contrast to now commonly used single dose amcentral'cylinder Iit contains a cotton filter 5.

pules hold two or more charges of medicament. The closure may bepractically any style of 25 Upon repeated use, the risk of contaminationor stopper or cap. Three examples appear in the inconvenient operationthrough creation of a vacsubsequent illustrations. uum has so farrendered this type of ampule un- Fig. 2 shows a stopper 6, provided withtwo holes serviceable. My invention is intended to remedy I and 8. Thelarge hole 8 will accommodate the this situation. Production of multipledose conair filter I; it is closed by the diaphragm 9. A 30 tainers isobviously less expensive in every refine hole I reaches from the top ofstopper 6 to spect than that of single dose ampules. the diaphragm II]at the lower end, or the hole is Some practitioners draw air into thesterilized interrupted by a diaphragm II, as in Fig. 3. syringe beforepuncturing the stopper. This air Figs. 3 and 3a exemplify the working ofthe air is then injected into the air space of'the container filter I incombination with the stopper 6 and 35 creating internal pressure. Therisk of contamithe container l2 in aspirating a solution into the nationduring this procedure is obvious. Some syringe I3. In inoperativeposition, the filter is manufacturers incorporate germicidal compoundsinserted into the large hole 8 to such depth as to into the medicinalsolutions, in order to destroy barely touch the diaphragm 9 withoutpenetrat- 4 the germs which gain access with the air. Howing it. Thesmall depression I I in Fig. 3 indicates 4 ever,- in order to accomplishreal antisepsis, the the location of the fine hole I and serves as agermicide must be present in suificient quantity guide for the needle l5of a hypodermic syrto be efiective. Such quantities of antiseptics inge'3 maycause irritation to the patient. An ideal A container I2 tightlyclosed with this stopper medicament should contain no ingredient which 6is operated by pushing the air filter I down un- 45 is therapeuticallyunnecessary and which may til the thumb-rest 3 contacts with the surfaceof bring discomfort to the patient. the stopper. The beveled aperture 4then' enters My novel type of container is designed to overthe air spacein the container I2. The fine hole come these drawbacks. For thatpurpose itis I guides the needle I5 of the hypodermic syringe closedwith a closure provided with an air filter I3 which penetrates therubber diaphragm In or 50 which permits equalization of pressure betweenII, and then permits withdrawal of the medicathe mitside and the airspace of the container ment.

upon aspiration of the solution into the hypo- Fig. 4 illustrates acombination of the stopper dermic syringe while avoiding the risk ofconin Figs. 3 and 3a with a screw-cap container. A

tamination. bottle IS with a screw-thread I! on the neck I8 55 is fittedwith the stopper 6 equipped with the air filter l and the needle hole I.A screw-cap i9 can then be attached in such manner as to cover thestopper.

Optional embodiments of a combined air filter and stopper are shown inFigs. 5 and 6.

Fig. 5 illustrates a rubber cap 20 which may be slipped over the neck ofa bottle in obvious manner. Upon using the outfit, the operator moistensthe surface of the rubber cap 20 with a 2% phenol solution or any otheraqueous germicide, and pushes filter I through the cap near its center.

The germicidal solution preserves sterility and facilitates penetrationof the rubber by the filter point. There is no necessity for a needlehole in this type, because the needle punctures the rubber easily in anyplace.

Fig. 6 shows another style of stopper 2| which in principle is like thatof Fig. 5, except that the skirt 2! of the closure member is longer andof lesser diameter.

In regard to the style of bottle, it has been found that a bottle witha. cylindrical neck and without lip is most suitable when rubber capsare used. For solid stoppers any kind of neck is satisfactory. For smallquantities of medicament up to one ounce there is nodifilculty in usingthe medicament to the last drop. For larger amounts than one ounce, afiat bottle with a neck near one side permits usage of the whole amountof the solutionby tipping the bottle when the amount of medicamentcontained therein is small.

The tube 2 in. the air filter i is filled with a column 5 ofnon-absorbent cotton. 'The cotton is preferably of long fiber quality.Being nonabsorbent, accidental contact with thesolution in the containerwill not interfere with its efiiciency as a filter. When the solution iswithdrawn from the bottle in the manner indicated, air filters in-germ-free condition into the air space of the bottle, equalizingpressure.

. It will be noted that the rubber diaphragms l and H or the rubber cap20 or it may he punctured many times with a hypodermic needle withoutrisk of admitting unfiltered air, and they will close automaticallyafter withdrawal of the needle due to the elasticity of the rubber.

Furthermore, after the air filter is properly placed, it remains in thesame position as long as is necessary to use up the whole contents ofthe container. There is no filing oi necks as with ampules and noexposure whatever to air contamination. Manipulation of my deviceissimple and safe.

It will be obvious from the above that the thumb-rest 3 of the airfilter i may be made of different diameter according to the size of thestopper to which it is fitted.

In practical application, the'container 52 may be shipped with the airfilter l in the stopper '3, or the air filter in a separate package,according to the style of the stopper.

A salt in dry form may be placed in the containers and the solvents maybe injected through a hypodermic needle connected with a syringe. Theair filter works in both directions and relieves the air pressure causedby injection of solvent.

Three series of bacteriological tests were made with these types ofclosures. These tests have shown that the air, after having beenfiltered by the device described herein, is actually germfree. Thedetailed report of these tests is as follows:

EFFICIENCY TESTS WITH RUBBER Srorrsas EQUIPPED WITH Are Frnms Firstseries, Figs 2 and 3 is made in the stopper to reach nearly to the Ilower end, thus leaving a diaphragm of rubber of about 2 m/m. thickness.The two stoppers are wrapped in paper and sterilized in an autoclave.After sterilization, the cotton plugs are removed from the bottles andthe stoppers are placed in the necks with aseptic precaution.

Varying amounts of the broth are removed dailyon several occasions twicedailyby means of a sterilized Luer syringe. The needle is passed throughthe fine hole in the rubber stopper. Each amount of broth thus removedis planted in a fermentation tube containing about 30 cubic centimetersof National Institute of Health broth and these fermentation tubes areincubated at 3'7 C. for seven days. The experiment terminated when thecontents of the bottles were exhausted. A total of 20 withdrawals weremade from the two-ounce bottle, and 10 from the one-ounce bottle. One ofthe bottles during the term of the experiment was kept at roomtemperature and the other one at 37 C. in the incubator. Thuscontamination of the contents of either bottle would become evident bothin the bottles and in the cultures made from the contents.

There was not a single fermentation tube showing contamination. Theseverity of the test is emphasized when it is considered that solutionsfor parenteral administration in the majority of cases do not containsubstances which are favorable for bacterial growth. On the other hand,the broth of the National Institute of Health is one of the best culturemedia known;

There was not the slightest air resistance when the broth was drawn upin the syringe. It was proved that air passes readily through the filterwhen the bottle is placed fiat on a table so that the end of the airfilter was submerged. As soon as the syringe piston is moved up, airbubbles rise in the fiuid.

This rubber stopper with the air filter makes possible the withdrawingof the solution without air resistance; it preserves sterility of thesolution for an indefinite period of time; and it makes possible theplacing of a number of doses in one container without danger ofcontaminating the solution when a dose is withdrawn.

Second series, see Fig. 3a

This series was made exactly as the first series, excepting that in thefirst series the needle hole in the stopper was made from the topto'near the bottom, while this second series was made with a stopperhaving a needle hole from the bottom to the top, leaving a diaphragm ofrubber at the top.

The results were as satisfactory as with the first series,

Third series, see Figs. 5 and 6 This third series of tests was made witha ruuber cap instead of a stopper (see Fig. 5). In this case the filteris inserted near the center of the cap. There is no needle hole in thecap. Instead, the cap is punctured by the sterilized needle in anysuitable place. The tests were repeated daily up to a time when aboutone-half of the volume of broth remained in the bottle.

For the last test the bottle is laid on a table at such an angle thatthe broth covers the aperture of the filter. A needle, attached to ahypodermic syringe is then inserted through the rubber cap and about twocubic centimeters of broth are drawn into the syringe. These two cubiccentimeters are planted in fermentation tubes containing NationalInstitute of Health broth. The end of the filter being submerged in thebroth, discharges the filtered air into the broth and it is thuspossible to watch the air bubbles pass rapidly through the broth.

A fermentation tube is inoculated with the contents of the syringe andthe bottle containing the This severe test proves the eificiency of theair filter.

This third series was made before an open window. a

The operation of' my device has above been described with respect to airas a contaminating agent. It is understood that other gaseous media asthey may be used in medicinal practice, such as nitrogen or carbondioxide, are within the scope of my invention and are intended to bewithin the purview of the appended claim.

What I claim is:

A medicinal container comprising in combination, a necked bottle and astopper tightly sealing the same, a system of openings provided in saidstopper which consists of channels traversing substantially the entirelength of the stopper, and an air filter arranged in one of saidchannels to disinfect atmospheric air prior to entering thespace oi thecontainer by operation of the system of openings, which filter comprisesin combination, a hollow, sharply beveled, tubeelike body, filled in itshollow space with a column of non-absorbent disinfecting cotton.

PAUL G. HEINEMAN.

